Modular flying lead cable and methods for use with heart pump controllers

ABSTRACT

An external controller assembly for a medical device implanted in a patient includes an external controller and an external driveline assembly. The external controller includes an external controller display viewable by the patient. The external driveline assembly includes an external driveline cable and an external driveline distal connector. The external driveline cable is connected to the external driveline distal connector and the external controller. The external driveline cable accommodates positioning of the external driveline distal connector, by the patient, for simultaneous viewing of the external driveline distal connector and the external controller display by the patient. The external driveline distal connector is adapted to be connected to the distal driveline proximal connector by the patient. The external driveline distal connector is adapted to be disconnected from the distal driveline proximal connector by the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit under 35 USC § 119(e) of USProvisional Appln. No. 62/646,174 filed Mar. 21, 2018; the fulldisclosure which is incorporated herein by reference in its entirety forall purposes.

BACKGROUND

Ventricular assist devices, known as VADs, often include an implantableblood pump and are used for both short-term (i.e., days, months) andlong-term applications (i.e., years or a lifetime) where a patient'sheart is incapable of providing adequate circulation, commonly referredto as heart failure or congestive heart failure. According to theAmerican Heart Association, more than five million Americans are livingwith heart failure, with about 670,000 new cases diagnosed every year.People with heart failure often have shortness of breath and fatigue.Years of living with blocked arteries and/or high blood pressure canleave a heart too weak to pump enough blood to the body. As symptomsworsen, advanced heart failure develops.

A patient suffering from heart failure may use a VAD while awaiting aheart transplant or as a long term therapy. A patient may also use a VADwhile recovering from heart surgery. Thus, a VAD can supplement a weakheart (i.e., partial support) or can effectively replace the naturalheart's function.

BRIEF SUMMARY

The following presents a simplified summary of some embodiments of theinvention in order to provide a basic understanding of the invention.This summary is not an extensive overview of the invention. It is notintended to identify key/critical elements of the invention or todelineate the scope of the invention. Its sole purpose is to presentsome embodiments of the invention in a simplified form as a prelude tothe more detailed description that is presented later.

In embodiments described herein, an external controller assembly for animplanted medical device (e.g., a implanted blood pump) includes anexternal controller and an external driveline assembly connected to, andextending from, the external controller. The external driveline assemblyincludes an external driveline distal connector and an externaldriveline cable extending between the external controller and theexternal driveline distal connector. In many embodiments, the externaldriveline distal connector is adapted so that a patient in which themedical device is implanted can (a) connect the external controllerassembly to a distal driveline assembly that is connected to theimplanted medical device, and (b) disconnect the external controllerassembly from the distal driveline assembly. In many embodiments, theexternal driveline cable has a length and flexibility that enables thepatient to position and orient the external driveline distal connectorto more easily align and connect the external driveline distal connectorwith a distal driveline proximal connector of the distal drivelineassembly. In many embodiments, the length and flexibility of theexternal driveline cable enables the patient to position and orient theexternal driveline distal connector to more easily disconnect theexternal driveline distal connector from the distal driveline proximalconnector. For example, in many embodiments, the external drivelineassembly enables the patient to position and orient the externaldriveline distal connector to directly observe the angular orientationof the external driveline distal connector relative to an insertion axisof the external driveline distal connector. In many embodiments, theexternal driveline assembly enables the patient to hold the externaldriveline distal connector in one hand and hold the distal drivelineproximal connector in the other hand in positions and orientations thatbest enable the patient to make the connection or the disconnection. Forexample, in many embodiments, the external driveline assembly enablesthe patient to position the external driveline distal connector and thedistal driveline proximal connector out in front of the patient whilethe external controller is disposed in a holder attached to a supportbelt worn by the patient, thereby enabling the patient to directlyobserve the connection and disconnection and apply sufficient force tomake the connection or the disconnection.

Thus, in one aspect, a blood circulation assist system includes animplantable blood pump, an external controller, a distal drivelineassembly, and an external driveline assembly. Power to operate theimplantable blood pump is supplied to the implantable blood pump via theexternal controller. The external controller includes an externalcontroller display viewable by a patient in which the implantable bloodpump is implanted. The distal driveline assembly includes a percutaneouscable connected to the implantable blood pump and a distal drivelineproximal connector electrically coupled with the percutaneous cable. Thepercutaneous cable has a skin-interface segment adapted to extendthrough a skin of the patient. The external driveline assembly includesan external driveline cable and an external driveline distal connector.The external driveline cable is connected to the external drivelinedistal connector and the external controller. The external drivelinecable accommodates positioning of the external driveline distalconnector, by the patient, for simultaneous viewing of the externaldriveline distal connector and the external controller display by thepatient. The external driveline distal connector is adapted to beconnected to the distal driveline proximal connector by the patient. Theexternal driveline distal connector is adapted to be disconnected fromthe distal driveline proximal connector by the patient.

In many embodiments of the blood circulation assist system, the externaldriveline cable has a length and a flexibility that enables the patientto position and/or orient the external driveline distal connector tofacilitate connection, by the patient, of the external driveline distalconnector to the distal driveline proximal connector and disconnection,by the patient, of the external driveline distal connector from thedistal driveline proximal connector. For example, in some embodiments,the external driveline cable has a length and a flexibility toaccommodate the positioning of the external driveline distal connector,by the patient, for simultaneous viewing of the external drivelinedistal connector and the external controller display by the patient. Insome embodiments, the length of the external driveline cable is from 5inches to 9 inches.

In some embodiments of the blood circulation assist system, the externaldriveline assembly is connected to the external controller so as toprevent disconnection of the external driveline assembly from theexternal controller without the use of a tool. For example, in someembodiments: (a) the external controller includes an external drivelineconnection port, (b) the external driveline assembly includes anexternal driveline proximal connector by which the external drivelinecable is connected to the external driveline connection port; and (c)the external controller includes an external driveline latchingmechanism that prevents the patient from disconnecting the externaldriveline proximal connector from the external driveline connection portwithout the use of a tool (e.g., a key, a specialized tool).

In some embodiments of the blood circulation assist system, the externalcontroller and the external driveline assembly are adapted to detectwhether the external driveline assembly is connected to the distaldriveline assembly. For example, in some embodiments: (a) the externaldriveline assembly includes a first connection lead and a secondconnection lead, (b) the second connection lead is electricallyconnected to the first connection lead while the external drivelinedistal connector is connected to the distal driveline proximalconnector, (c) the second connection lead is electrically disconnectedfrom the first connection lead while the external driveline distalconnector is not connected to the distal driveline proximal connector,and (d) the external controller detects whether the external drivelinedistal connector is connected to the distal driveline proximal connectorby detecting whether the second connection lead is electricallyconnected to the first connection lead.

In many embodiments of the blood circulation assist system, the distaldriveline assembly includes a percutaneous driveline assembly and anintermediate driveline assembly. In such embodiments, the intermediatedriveline assembly can include the distal driveline proximal connector,an intermediate driveline cable, and an intermediate driveline distalconnector. The intermediate driveline cable connects the distaldriveline proximal connector to the intermediate driveline distalconnector. In such embodiments, the percutaneous driveline assembly caninclude a percutaneous driveline proximal connector and the percutaneouscable. The percutaneous driveline proximal connector is connectable tothe intermediate driveline distal connector. In many embodiments, thepercutaneous driveline proximal connector and the intermediate drivelinedistal connector are adapted to be connected so that the patient cannotdisconnect the intermediate driveline distal connector and thepercutaneous driveline proximal connector by hand. For example, in someembodiments, the blood circulation assist system includes anintermediate driveline latching mechanism that prevents disconnection ofthe percutaneous driveline proximal connector and the intermediatedriveline distal connector without the use of a tool, which in someembodiments is a specialized tool. In some embodiments, the distaldriveline assembly has a flexibility and an exterior length from theskin-interface segment to the distal driveline proximal connector thataccommodates positioning of the distal driveline proximal connector, bythe patient, between the external controller display and an eye of thepatient. In some embodiments, the exterior length of the distaldriveline assembly is from 3 inches to 7 inches.

In another aspect, a method of connecting an external controller to ablood pump implanted in a patient is provided. The method includesconnecting a distal end of a percutaneous driveline assembly to theblood pump. The percutaneous driveline assembly includes a percutaneousdriveline cable and a percutaneous driveline proximal connector. Thepercutaneous driveline cable extends between the blood pump and thepercutaneous driveline proximal connector. The percutaneous drivelinecable has a skin-interface segment that extends through a skin of thepatient. The method further includes connecting an intermediatedriveline assembly to the percutaneous driveline assembly by connectingan intermediate driveline distal connector of the intermediate drivelineassembly to the percutaneous driveline proximal connector. Theintermediate driveline assembly includes an intermediate drivelineproximal connector and an intermediate driveline cable connecting theintermediate driveline distal connector and the intermediate drivelineproximal connector. The method further includes connecting an externalcontroller assembly to the intermediate driveline assembly. The externalcontroller assembly includes an external driveline assembly and anexternal controller via which power is supplied to the blood pump. Theexternal driveline assembly includes an external driveline cable and anexternal driveline distal connector. The external driveline cableconnects the external driveline distal connector with the externalcontroller. The external controller includes an external controllerdisplay viewable by the patient. The external driveline cableaccommodates positioning of the external driveline distal connector, bythe patient, for simultaneous viewing of the external driveline distalconnector and the external controller display by the patient.

In many embodiments of the method, the external driveline assembly issecured to the external controller and/or the intermediate drivelineassembly is secured to the percutaneous driveline assembly so as toprevent disconnection without the use of a tool (e.g., a key, aspecialized tool). For example, in some embodiments, the method furtherincludes securing the intermediate driveline distal connector to thepercutaneous driveline proximal connector so as to prevent the patientfrom disconnecting the intermediate driveline distal connector from thepercutaneous driveline proximal connector without the use of a tool,which in some embodiments is a specialized tool. In some embodiments,the method further includes: (a) connecting the external drivelineassembly to the external controller by connecting an external drivelineproximal connector of the external driveline assembly to an externaldriveline connection port of the external controller, and (b) securingthe external driveline proximal connector to the external drivelineconnection port so as to prevent the patient from disconnecting theexternal driveline proximal connector from the external drivelineconnection port without the use of a tool (e.g., a key, a specializedtool).

In many embodiments of the method, the external driveline cable has alength and a flexibility that enables the patient to position and/ororient the external driveline distal connector to facilitate connection,by the patient, of the external driveline distal connector to theintermediate driveline proximal connector and disconnection, by thepatient, of the external driveline distal connector from theintermediate driveline proximal connector. For example, in someembodiments, the external driveline cable has a length and a flexibilityto accommodate the positioning of the external driveline distalconnector, by the patient, for simultaneous viewing of the externaldriveline distal connector and the external controller display by thepatient. In some embodiments of the method, the length of the externaldriveline cable is from 5 inches to 9 inches.

In another aspect, an external controller assembly for an implantedblood pump assembly includes an external controller and an externaldriveline assembly. Power can be supplied to the implantable blood pumpvia the external controller. The external controller includes anexternal controller display viewable by the patient. The externaldriveline assembly includes an external driveline cable and an externaldriveline distal connector. The external driveline cable is connected tothe external driveline distal connector and the external controller. Theexternal driveline cable accommodates positioning of the externaldriveline distal connector, by the patient, for simultaneous viewing ofthe external driveline distal connector and the external controllerdisplay by the patient. The external driveline distal connector isadapted to be connected to a distal driveline proximal connector of adistal driveline assembly by the patient. The external driveline distalconnector is adapted to be disconnected from the distal drivelineproximal connector by the patient.

In many embodiments of the external controller assembly, the externaldriveline cable has a length and a flexibility to accommodate thepositioning of the external driveline distal connector, by the patient,for simultaneous viewing of the external driveline distal connector andthe external controller display by the patient. In some embodiments, thelength of the external driveline cable is from 5 inches to 9 inches.

In some embodiments of the external controller assembly, the externaldriveline is connected to the external controller so as to preventdisconnection of the external driveline from the external controllerwithout the use of a tool. For example, in some embodiments: (a) theexternal controller includes an external driveline connection port, (b)the external driveline assembly includes an external driveline proximalconnector by which the external driveline cable is connected to theexternal driveline connection port; and (c) the external controllerincludes an external driveline latching mechanism that prevents thepatient from disconnecting the external driveline proximal connectorfrom the external driveline connection port without the use of a tool(e.g., a key, a specialized tool).

In some embodiments of the external controller assembly, the externalcontroller and the external driveline assembly are adapted to detectwhether the external driveline assembly is connected to the distaldriveline assembly. For example, in some embodiments: (a) the externaldriveline assembly includes a first connection lead and a secondconnection lead, (b) the second connection lead is electricallyconnected to the first connection lead while the external drivelinedistal connector is connected to the distal driveline proximalconnector, (c) the second connection lead is electrically disconnectedfrom the first connection lead while the external driveline distalconnector is not connected to the distal driveline proximal connector,and (d) the external controller detects whether the external drivelinedistal connector is connected to the distal driveline proximal connectorby detecting whether the second connection lead is electricallyconnected to the first connection lead.

For a fuller understanding of the nature and advantages of the presentinvention, reference should be made to the ensuing detailed descriptionand accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a blood circulation assist system that includes anexternal controller assembly including an external controller and anexternal driveline assembly connected to, and extending from, theexternal controller, in accordance with many embodiments.

FIG. 2 is an exploded view illustrating driveline assemblies of theblood circulation assist system of FIG. 1.

FIG. 3 is an exploded view illustrating connection of the externalcontroller assembly with a distal driveline assembly in the bloodcirculation assist system of FIG. 1.

FIG. 4 is a simplified block diagram of a method of connecting anexternal controller to a blood pump implanted in a patient, inaccordance with many embodiments.

FIG. 5 shows an embodiment of a patient-operable connection assembly forconnecting an external controller to a blood pump implanted in a patientand disconnecting the external controller to the blood pump.

FIG. 6 shows another embodiment of a patient-operable connectionassembly for connecting an external controller to a blood pump implantedin a patient and disconnecting the external controller to the bloodpump.

FIG. 7 shows another embodiment of a patient-operable connectionassembly for connecting an external controller to a blood pump implantedin a patient and disconnecting the external controller to the bloodpump.

FIG. 8 shows another embodiment of a patient-operable connectionassembly for connecting an external controller to a blood pump implantedin a patient and disconnecting the external controller to the bloodpump.

FIG. 9 shows another embodiment of a patient-operable connectionassembly for connecting an external controller to a blood pump implantedin a patient and disconnecting the external controller to the bloodpump.

DETAILED DESCRIPTION

In the following description, various embodiments of the presentinvention will be described. For purposes of explanation, specificconfigurations and details are set forth in order to provide a thoroughunderstanding of the embodiments. However, it will also be apparent toone skilled in the art that the present invention may be practicedwithout the specific details. Furthermore, well-known features may beomitted or simplified in order not to obscure the embodiment beingdescribed.

Embodiments described herein are directed to improving the ability of apatient to reliably and effectively connect an external controller to adriveline assembly connected to an implanted medical device (e.g., animplanted blood pump). In contrast to embodiments described herein, someexisting external controllers are difficult to connect to a drivelineassembly connected to an implanted medical device. For example, someexisting external controllers have a display and a connection port forthe driveline assembly that is positioned and oriented so the patientcannot simultaneously view the display and the connection port, therebypreventing the patient from monitoring the display while viewing theconnection port. In such existing external controllers, the location andorientation of the connection port contributes to poor ergonomics whenattempting to align a proximal connector of the driveline assembly withthe connection port during connection of the driveline assembly to theexternal controller. Moreover, in such existing controllers, arelatively high connection force may be required to connect the proximalconnector of the driveline assembly to the connection port of theexternal controller.

Embodiments described herein include and/or employ an externalcontroller assembly that includes an external controller and an externaldriveline assembly connected to, and extending from, the externalcontroller. The external driveline assembly includes an externaldriveline distal connector and an external driveline cable by which theexternal driveline distal connector is connected to the externalcontroller and by which the external driveline distal connector isdisposed at a distance from the external controller. The externaldriveline assembly moves the patient interaction area away from theexternal controller. Moving the patient interaction area away from theexternal controller enables the patient to connect the externaldriveline distal connector to the proximal connector of the drivelineassembly while simultaneously observing the connection and directlymonitoring a display of the external controller for a displayedindication that the connection is complete. In many embodiments, theexternal driveline assembly allows the patient to comfortably grasp theexternal driveline distal connector in one hand and the proximalconnector of the driveline assembly in the other hand while making theconnection between the external driveline distal connector and theproximal connector of the distal driveline assembly. In manyembodiments, connection of the external driveline distal connector andthe proximal connector of the distal driveline assembly can be madeusing a suitable insertion force that can be generated by most patients.In some embodiments, the external driveline assembly is compatible withexisting external controllers.

In many embodiments, the external driveline assembly ispseudo-permanently attached to a connection port of the externalcontroller. The connection of the external driveline assembly to theconnection port of the external controller can be made duringmanufacture of the external controller assembly and/or by a trainedtechnician.

Referring now to the drawings, in which like reference numeralsrepresent like parts throughout the several views, FIG. 1 illustrates ablood circulation assist system 10 being used by a patient 12, inaccordance with many embodiments. The blood circulation assist system 10includes an implantable blood pump 14, a blood flow conduit 16, apercutaneous driveline assembly 18, an intermediate driveline assembly20, an external driveline assembly 22, an external controller 24, afirst battery 26, a first battery cable 28, a second battery 30, asecond battery cable 32, and a support harness 34. The support harness34 has receptacles that hold the first battery 26 and the second battery30. In many embodiments, the external controller 24 is mountable to thesupport harness 34 to hold the external controller 24 in a suitableposition and orientation relative to the patient 12, such as theposition and orientation of the external controller 24 relative to thepatient 12 illustrated in FIG. 1.

In a regular operation mode, the blood pump 14 is powered via electricalpower supplied by the first battery 26 via the first battery cable 28and/or by the second battery 30 via the second battery cable 32.Electrical power supplied by the first battery 26 and/or the secondbattery 30 is transmitted, via the external controller 24, over theexternal driveline assembly 22, the intermediate driveline assembly 20,and the percutaneous driveline assembly 18 to the blood pump 14. In theillustrated embodiment, the blood pump 14 is a left ventricle assistdevice (LVAD) that pumps blood from the left ventricle of the patient 12to the aorta of the patient 12 via the blood flow conduit 16.

The external driveline assembly 22 can be used in connection with anysuitable implanted medical device. In the illustrated embodiment, theblood pump 14 is a left ventricle assist device (LVAD) that pumps bloodfrom the left ventricle of the patient 12 to the aorta of the patient 12via the blood flow conduit 16. In many embodiments, the externaldriveline assembly 22 is connectable, by the patient 12, to theintermediate driveline assembly 20 via a patient-operable connectionassembly 64. In many embodiments, the external driveline assembly 22 canbe disconnected, by the patient 12, from the intermediate drivelineassembly 20 via the patient-operable connection assembly 64.

FIG. 2 is an exploded view illustrating connection of the externalcontroller 24 to the blood pump 14 via the combination of thepercutaneous driveline assembly 18, the intermediate driveline assembly20, and the external driveline assembly 22. The external drivelineassembly 22 includes an external driveline distal connector 36, anexternal driveline cable 38, and an external driveline proximalconnector 40. The intermediate driveline assembly 20 includes anintermediate driveline distal connector 42, an intermediate drivelinecable 44, and an intermediate driveline proximal connector 46. Thepercutaneous driveline assembly 18 includes a percutaneous drivelinedistal connector 48, a percutaneous driveline cable 50, and apercutaneous driveline proximal connector 52. The percutaneous drivelinecable 50 includes a skin-interface portion 54. The external controller24 includes an external driveline connection port 56. The blood pump 14includes a percutaneous driveline connector 58. The external drivelineassembly 22 is connectable to the external controller 24 via insertionof the external driveline proximal connector 40 into the externaldriveline connection port 56. The external driveline assembly 22 isconnectable to the intermediate driveline assembly 20 via connection ofthe external driveline distal connector 36 and the intermediatedriveline proximal connector 46. The intermediate driveline assembly 20is connectable to the percutaneous driveline assembly 18 via connectionof the intermediate driveline distal connector 42 and the percutaneousdriveline proximal connector 52. The percutaneous driveline assembly 18is connected to the blood pump 14 via connection of the percutaneousdriveline distal connector 48 and the percutaneous driveline connector58.

In many embodiments, the external controller 24 includes an externaldriveline latch mechanism that can be reconfigured between a connectionconfiguration that accommodates connection of the external drivelineproximal connector 40 to the external driveline connection port 56 and aretention configuration that blocks disconnection of the externaldriveline proximal connector 40 from the external driveline connectionport 56. In some embodiments, reconfiguration of the external drivelinelatch mechanism between the connection configuration and the retentionconfiguration requires the use of a tool (e.g., a key, a specializedtool). For example, the external driveline latch mechanism can include akey-operated locking mechanism operable to lock the external drivelinelatch mechanism in the retention configuration and requiring the use ofa key to reconfigure the external driveline latch mechanism from theretention configuration to the connection configuration. In someembodiments, reconfiguration of the external driveline latch mechanismbetween the connection configuration and the retention configurationdoes not require the use of a tool (e.g., a key, a specialized tool).

In some embodiments, the connection between the intermediate drivelineassembly 20 and the percutaneous driveline assembly 18 preventsdisconnection of the intermediate driveline distal connector 42 and thepercutaneous driveline proximal connector 52 without the use of a tool(e.g., a specialized tool not typically possessed by the patient). Forexample, the connection between the intermediate driveline distalconnector 42 and the percutaneous driveline proximal connector 52 can besecured via a retainer ring that prevents disconnection without removalof the retainer ring via the use of a retainer ring plier. In someembodiments, the connection between the intermediate driveline assembly20 and the percutaneous driveline assembly 18 accommodates disconnectionof the intermediate driveline distal connector 42 and the percutaneousdriveline proximal connector 52 without the use of a tool.

In the event of a fault in the external controller 24, it may benecessary to replace the faulted external controller to avoid potentialdetrimental prolonged disruption of operation of the blood pump 14. FIG.3 is an exploded view illustrating the external controller 24, theexternal driveline assembly 22, and the intermediate driveline assembly20. To facilitate replacement of the external controller 24 in the bloodcirculation assist system 10, in many embodiments, the externaldriveline assembly 22 can be connected to the intermediate drivelineassembly 20 and disconnected from the intermediate driveline assembly 20by the patient without the use of a tool. For example, in theillustrated embodiment, the external driveline distal connector 36 isconfigured as a female connector assembly and the intermediate drivelineproximal connector 46 is configured as a male assembly that is insertedinto the external driveline distal connector 36 by the patient. In theillustrated embodiment, the external driveline distal connector 36includes a rotatable retention collar 60 that the patient can rotate, byhand without the use of a tool, between a connection orientation inwhich the retention collar 60 accommodates insertion of the intermediatedriveline proximal connector 46 into the external driveline distalconnector 36 and a retention orientation in which the retention collar60 blocks disconnection of the intermediate driveline proximal connector46 from the external driveline distal connector 36. In some embodiments,the retention collar 60 is rotatable by the patient through less than afull revolution (e.g., by a quarter turn, by a half turn) between theretention orientation and the connection orientation.

In some embodiments, the external controller 24 and the externaldriveline assembly 22 are adapted to detect whether the externaldriveline assembly 22 is connected to the intermediate drivelineassembly 20 and display an indication on the external controller display62 indicative of whether the external driveline assembly 22 is connectedto the intermediate driveline assembly 20. For example, in someembodiments, the external driveline assembly 22 includes a firstconnection lead and a second connection lead. The second connection leadis electrically connected to the first connection lead while theexternal driveline distal connector 36 is connected to the distaldriveline proximal connector 46. The second connection lead iselectrically disconnected from the first connection lead while theexternal driveline distal connector 36 is not connected to the distaldriveline proximal connector 46. The external controller 24 detectswhether the external driveline distal connector 36 is connected to thedistal driveline proximal connector 46 by detecting whether the secondconnection lead is electrically connected to the first connection lead.In many embodiments, the external controller 24 displays an indicator 63on the external controller display 62 indicative of whether the externaldriveline distal connector 36 is connected to the distal drivelineproximal connector 46. The displayed indicator 63 provides feedback tothe patient as to whether the external driveline distal connector 36 isconnected to the distal driveline proximal connector 46.

In many embodiments, the external driveline cable 38 has a length and aflexibility that enables the patient to position and/or orient theexternal driveline distal connector 36 to facilitate connection, by thepatient, of the external driveline distal connector 36 to theintermediate driveline proximal connector 46 and disconnection, by thepatient, of the external driveline distal connector 36 from theintermediate driveline proximal connector 46. For example, in someembodiments, the external driveline cable 38 has a length and aflexibility to accommodate the positioning of the external drivelinedistal connector 38, by the patient, for simultaneous viewing of theexternal driveline distal connector 36 and an external controllerdisplay 62 by the patient. In some embodiments, the length of theexternal driveline cable 38 and/or the overall length of the externaldriveline assembly 22 is from 5 inches to 9 inches.

FIG. 4 is a simplified block diagram of a method 100 of connecting anexternal controller to a blood pump implanted in a patient, inaccordance with many embodiments. While the method 100 is describedherein with reference to the blood circulation assist system 10, themethod 100 can be practiced with respect to connecting any suitableexternal controller to any suitable medical device implanted in apatient.

The method 100 includes connecting a distal end of the percutaneousdriveline assembly 18 to an implantable blood pump (act 102). Forexample, in the system 10, the percutaneous driveline distal connector48 is connected to the percutaneous driveline connector 58. In manyembodiments, the method 100 further includes securing the connectionbetween the percutaneous driveline distal connector 48 and thepercutaneous driveline connector 58 so as to prevent inadvertentdisconnection thereof. For example, a suitable latching mechanism can beemployed and reconfigured from a connection configuration accommodatingthe connection of the percutaneous driveline distal connector 48 to thepercutaneous driveline connector 58 to a retention configuration thatblocks disconnection of the percutaneous driveline distal connector 48from the percutaneous driveline connector 58. In many embodiments, themethod 100 further includes implanting a distal portion of thepercutaneous driveline assembly 18 within the patient so that theskin-interface portion 54 of the percutaneous driveline cable 50 extendsthrough an aperture through the skin of the patient with theskin-interface portion 54 interfacing with an edge of the skin at theaperture and the remaining proximal portion being disposed exterior tothe patient.

The method 100 further includes connecting the intermediate drivelineassembly 20 to the percutaneous driveline assembly 18 by connecting theintermediate driveline distal connector 42 to the percutaneous drivelineproximal connector 52 (act 104). In many embodiments, the method 100further includes securing the connection between the intermediatedriveline distal connector 42 and the percutaneous driveline proximalconnector 52 so as to prevent disconnection by the patient without theuse of a specialized tool. For example, the connection between theintermediate driveline distal connector 42 and the percutaneousdriveline proximal connector 52 can be secured by installing a retainerring using a retainer ring plier so as to engage a respective retainergroove in each of the intermediate driveline distal connector 42 and thepercutaneous driveline proximal connector 52.

The method 100 further includes connecting an external controllerassembly to the intermediate driveline assembly 20 (act 106). Forexample, in the system 10, the external controller assembly includes theexternal driveline assembly 22 and the external controller 24. Theexternal driveline assembly 22 is connected to the intermediatedriveline assembly 20 by connecting the external driveline distalconnector 36 to the intermediate driveline proximal connector 40. Inmany embodiments, the connection between the external driveline distalconnector 36 and the intermediate driveline proximal connector 40 ispatient-operable to accommodate connection and disconnection thereof, bythe patient, to enable the patient to replace the external controllerassembly with a replacement external controller assembly. In someembodiments, the method 100 further includes: (a) connecting theexternal driveline assembly 22 to the external controller 24 byconnecting the external driveline proximal connector 40 to the externalcontroller driveline connection port 56, and (b) securing the externaldriveline proximal connector 40 to the external controller drivelineconnection port 56 so as to prevent the patient from disconnecting theexternal driveline proximal connector 40 from the external controllerdriveline connection port 56 without the use of a key or a specializedtool. In alternate embodiments of the external controller assembly, theexternal driveline assembly 22 is integrally attached to the externalcontroller 24 so that the external controller 24 does not include theexternal controller driveline connection port 56 and the externaldriveline assembly 22 does not include the external driveline proximalconnector 40.

In many embodiments of the method, the external driveline cable 38 has alength and a flexibility that enables the patient to position and/ororient the external driveline distal connector 36 to facilitateconnection, by the patient, of the external driveline distal connector36 to the intermediate driveline proximal connector 46 anddisconnection, by the patient, of the external driveline distalconnector 36 from the intermediate driveline proximal connector 46. Forexample, in some embodiments, the external driveline cable 38 has alength and a flexibility to accommodate the positioning of the externaldriveline distal connector 36, by the patient, for simultaneous viewingof the external driveline distal connector 36 and the externalcontroller display 62 by the patient. In some embodiments of the method,the length of the external driveline cable 38 is from 5 inches to 9inches.

FIG. 5 shows a patient-operable connection assembly 110 that can beemployed in the patient-operable connection assembly 64 shown in FIG. 1.The connection assembly 110 includes a male connector component 112 anda female connector assembly 114. The female connector assembly 114 has areceptacle 118 and a latching mechanism 120. The male connectorcomponent 112 has an end portion 116 that has a retention groove 122. Insome embodiments, the end portion 116 has one or more alignment featuresthat engage complementarily-shaped alignment features of the femaleconnector assembly 114 to ensure alignment with electrical contactssupported by the male connector component 112 with electrical contactssupported by the female connector assembly 114. The end portion 116 isadapted to be inserted into the receptacle 118 and retained in thereceptacle 118 via engagement between the latching mechanism 120 and theretention groove 122. In some embodiments, the latching mechanism 120 isspring-biased towards a retention configuration in which the latchingmechanism 120 is configured to retain the end portion 116 in thereceptacle 118 via engagement with the retention groove 122. In suchembodiments, insertion of the end portion 116 into the receptacle 118induces a reconfiguration cycle in which interaction between the endportion 116 and the latching mechanism 120 causes the latching mechanism120 to reconfigure so as to accommodate full insertion of the endportion 116 into the receptacle 118 to a depth where the retentiongroove 122 is positioned to be engaged by the latching mechanism 120. Insuch embodiments, once the end portion 116 is fully inserted into thereceptacle 118, the latching mechanism 120 self-reconfigures back to theretention configuration, thereby engaging the retention groove 122 toprevent inadvertent decoupling of the male connector component 112 andthe female connector assembly 114. In many embodiments, the latchingmechanism 120 can be manually reconfigured by the patient from theretention configuration to a release configuration in which the maleconnector component 112 can be decoupled from the female connectorassembly 114. For example, in many embodiments, the patient can push orpull on the latching mechanism 120 to reconfigure the latching mechanism120 from the retention configuration to the release configuration toenable the patient to decouple the male connector component 112 from thefemale connector assembly 114. The male connector component 112 can beincluded in the intermediate driveline proximal connector 46. The femaleconnector assembly 114 can be included in the external driveline distalconnector 36.

FIG. 6 shows a patient-operable connection assembly 130 that can beemployed in the patient-operable connection assembly 64 shown in FIG. 1.The connection assembly 130 includes a male connector component 132 anda female connector assembly 134. The female connector assembly 114includes a base member 136 and latching members 138 that are pivotallymounted to the base member 136. The base member 136 defines a receptacle140. The male connector component 132 has an end portion 142. In someembodiments, the end portion 142 has one or more alignment features thatengage complementarily-shaped alignment features of the base member 136to ensure alignment with electrical contacts supported by the maleconnector component 132 with electrical contacts supported by the femaleconnector assembly 134. The end portion 142 is adapted to be insertedinto the receptacle 140 and retained in the receptacle 140 via couplingof the latching members 138 with the male connector component 132. Forexample, in some embodiments, the male connector component 132 includescoupling features to which the latching members 138 can be selectivelycoupled with by the patient and decoupled from by the patient. The maleconnector component 132 can be included in the intermediate drivelineproximal connector 46. The female connector assembly 134 can be includedin the external driveline distal connector 36.

FIG. 7 shows a patient-operable connection assembly 150 that can beemployed in the patient-operable connection assembly 64 shown in FIG. 1.The connection assembly 150 includes a first connector component 152 anda second connector component 154. The first connector component 152 hasretention features 158, 160. The second connector component 154 hasretention features 162, 164. Each of the retention features 158 definesa slot 166 shaped to accommodate and engage a respective retentionfeature 164 when the connection assembly 150 is in a coupledconfiguration. Likewise, each of the retention features 162 defines aslot 166 shaped to accommodate and engage a respective retention feature160 when the connection assembly 150 is in the coupled configuration.The connection assembly 150 is connectable by the patient via relativetranslation between the first connector component 152 and the secondconnector component 154 along a connection axis 156 to bring the firstconnector component 152 and the second connector component 154 intoengagement in an intermediate configuration, followed by relativerotation between the first connector component 152 and the secondconnector component 154 around the connection axis 156 from theintermediate configuration into the coupled configuration. Theconnection assembly 150 can be disconnected by the patient via relativerotation between the first connector component 152 and the secondconnector component 154 around the connection axis 156 from the coupledconfiguration to the intermediate configuration, followed by relativetranslation between the first connector component 152 and the secondconnector component 154 along a connection axis 156 to separate thefirst connector component 152 and the second connector component 154. Insome embodiments, the connection assembly 150 includes apatient-operable retention mechanism that prevents relative rotationbetween the first connector component 152 and the second connectorcomponent 154 in the coupled configuration of the connection assembly150 absent reconfiguration of the retention mechanism by the patientinto a release configuration that accommodates relative rotation betweenthe first connector component 152 and the second connector component154. The first connector component 152 can be included in theintermediate driveline proximal connector 46. The second connectorcomponent 154 can be included in the external driveline distal connector36.

FIG. 8 shows a patient-operable connection assembly 170 that can beemployed in the patient-operable connection assembly 64 shown in FIG. 1.The connection assembly 170 includes a male connector component 172 anda female connector assembly 174. The female connector assembly 174 has areceptacle 176 and a translatable latching member 178. The maleconnector component 172 has an end portion 180. In some embodiments, theend portion 180 has one or more alignment features that engagecomplementarily-shaped alignment features of the female connectorassembly 174 to ensure alignment with electrical contacts supported bythe male connector component 172 with electrical contacts supported bythe female connector assembly 174. The end portion 180 is adapted to beinserted into the receptacle 176 and retained in the receptacle 176 viaengagement with the latching member 178. In some embodiments, thelatching member 178 is spring-biased towards a retention configurationin which the female connector assembly 174 is configured to retain theend portion 180 in the receptacle 176. In some embodiments, insertion ofthe end portion 180 into the receptacle 176 induces a reconfigurationcycle in which interaction between the end portion 180 and the latchingmember 178 causes the latching member 178 to translate so as toaccommodate full insertion of the end portion 180 into the receptacle176. In such embodiments, once the end portion 180 is fully insertedinto the receptacle 176, the latching member 178 translates back to theretention configuration, thereby engaging the end portion 180 to preventinadvertent decoupling of the male connector component 172 and thefemale connector assembly 174. In many embodiments, the latching member178 can be manually translated by the patient from the retentionconfiguration to a release configuration in which the male connectorcomponent 172 can be decoupled from the female connector assembly 174.For example, in many embodiments, the patient can translate the latchingmember 178 to reconfigure the female connector assembly 174 from theretention configuration to the release configuration to enable thepatient to decouple the male connector component 172 from the femaleconnector assembly 174. The male connector component 172 can be includedin the intermediate driveline proximal connector 46. The femaleconnector assembly 174 can be included in the external driveline distalconnector 36.

FIG. 9 shows a patient-operable connection assembly 190 that can beemployed in the patient-operable connection assembly 64 shown in FIG. 1.The connection assembly 190 includes a male connector component 192 anda female connector assembly 194. The female connector assembly 194 has alatching mechanism that includes a patient-operable release button 196that can be pressed by the patient to enable decoupling of the maleconnector component 192 from the female connector assembly 194. In manyembodiments, the connection assembly 190 is configured similar to theconnection assembly 110 with respect to the ability of the latchingmechanism to accommodate insertion of the male connector component 192into the female connector assembly 194 and have the latching mechanismautomatically reconfigure into the retention configuration upon fullinsertion of the male connector component 192 into the female connectorassembly 194. In many embodiments, the release button 196 is recessedrelative to the surrounding adjacent exterior surface of the femaleconnector assembly 194 to prevent inadvertent pressing of the releasebutton 196. The male connector component 192 can be included in theintermediate driveline proximal connector 46. The female connectorassembly 194 can be included in the external driveline distal connector36.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A blood circulation assist system, comprising: animplantable blood pump; an external controller via which power tooperate the implantable blood pump is supplied to the implantable bloodpump, the external controller including an external controller displayviewable by a patient in which the implantable blood pump is implanted;a distal driveline assembly comprising a percutaneous cable connected tothe implantable blood pump and a distal driveline proximal connectorelectrically coupled with the percutaneous cable, the percutaneous cablehaving a skin-interface segment adapted to extend through a skin of apatient, wherein the distal driveline assembly has a flexibility and anexterior length from the skin-interface segment to the distal drivelineproximal connector that accommodates positioning of the distal drivelineproximal connector, by the patient, between the external controllerdisplay and an eye of the patient, and wherein the exterior length ofthe distal driveline assembly is from 3.0 inches to 7.0 inches; and anexternal driveline assembly comprising an external driveline cable andan external driveline distal connector, the external driveline cablebeing connected to the external driveline distal connector and theexternal controller, the external driveline cable accommodatingpositioning of the external driveline distal connector, by the patient,for simultaneous viewing of the external driveline distal connector andthe external controller display by the patient, wherein the externaldriveline distal connector is adapted to be connected to the distaldriveline proximal connector by the patient, and wherein the externaldriveline distal connector is adapted to be disconnected from the distaldriveline proximal connector by the patient, wherein the externalcontroller and the external driveline assembly are adapted to detectwhether the external driveline assembly is connected to the distaldriveline assembly and display an indication on the external controllerdisplay indicative of whether the external driveline assembly isconnected to the distal driveline assembly.
 2. The blood circulationassist system of claim 1, wherein the external driveline cable has alength and a flexibility to accommodate the positioning of the externaldriveline distal connector, by the patient, for simultaneous viewing ofthe external driveline distal connector and the external controllerdisplay by the patient.
 3. The blood circulation assist system of claim2, wherein the length of the external driveline cable is from 5 inchesto 9 inches.
 4. The blood circulation assist system of claim 3, wherein:the external controller comprises an external driveline connection port;the external driveline assembly comprises an external driveline proximalconnector that is connects the external driveline cable to the externaldriveline connection port; and the external controller comprises anexternal driveline latching mechanism that prevents the patient fromdisconnecting the external driveline proximal connector from theexternal driveline connection port without use of a tool.
 5. The bloodcirculation assist system of claim 1, wherein: the external drivelineassembly comprises a first connection lead and a second connection lead;the second connection lead is electrically connected to the firstconnection lead while the external driveline distal connector isconnected to the distal driveline proximal connector; the secondconnection lead is electrically disconnected from the first connectionlead while the external driveline distal connector is not connected tothe distal driveline proximal connector; and the external controllerdetects whether the external driveline distal connector is connected tothe distal driveline proximal connector by detecting whether the secondconnection lead is electrically connected to the first connection lead.6. The blood circulation assist system of claim 1, wherein the distaldriveline assembly comprises: an intermediate driveline assembly thatincludes the distal driveline proximal connector, an intermediatedriveline cable, and an intermediate driveline distal connector; theintermediate driveline cable connecting the distal driveline proximalconnector to the intermediate driveline distal connector; and apercutaneous driveline assembly that includes a percutaneous drivelineproximal connector and the percutaneous cable, the percutaneousdriveline proximal connector being connectable to the intermediatedriveline distal connector.
 7. The blood circulation assist system ofclaim 6, wherein the percutaneous driveline proximal connector and theintermediate driveline distal connector are adapted to be connected sothat the patient cannot disconnect the intermediate driveline distalconnector and the percutaneous driveline proximal connector without useof a tool.
 8. The blood circulation assist system of claim 7, furthercomprising an intermediate driveline latching mechanism that preventsdisconnection of the percutaneous driveline proximal connector and theintermediate driveline distal connector without use of a specializedtool.
 9. The blood circulation assist system of claim 1, wherein: theexternal driveline distal connector and the distal driveline proximalconnector are included in a patient-operable connection assembly; thepatient-operable connection assembly comprises a latching mechanismhaving a retention configuration and a release configuration; thelatching mechanism blocks decoupling of the external driveline distalconnector from the distal driveline proximal connector in the retentionconfiguration; the latching mechanism accommodates decoupling of theexternal driveline distal connector from the distal driveline proximalconnector in the release configuration; and the latching mechanism isreconfigurable by the patient from the retention configuration to therelease configuration.
 10. The blood circulation assist system of claim9, wherein the latching mechanism is reconfigured from the retentionconfiguration to the release configuration via relative rotation of theexternal driveline distal connector and the distal driveline proximalconnector by the patient.
 11. The blood circulation assist system ofclaim 9, wherein the latching mechanism comprises a latching member thatis operated by the patient to reconfigure the latching mechanism fromthe retention configuration to the release configuration.
 12. A methodof connecting an external controller to a blood pump implanted in apatient, the method comprising: connecting a distal end of apercutaneous driveline assembly to the blood pump, the percutaneousdriveline assembly comprising a percutaneous driveline cable and apercutaneous driveline proximal connector, the percutaneous drivelinecable extending between the blood pump and the percutaneous drivelineproximal connector, the percutaneous driveline cable having askin-interface segment that extends through a skin of the patient;connecting an intermediate driveline assembly to the percutaneousdriveline assembly by connecting an intermediate driveline distalconnector of the intermediate driveline assembly to the percutaneousdriveline proximal connector, the intermediate driveline assemblycomprising an intermediate driveline proximal connector and anintermediate driveline cable connecting the intermediate drivelinedistal connector and the intermediate driveline proximal connector;connecting an external controller assembly to the intermediate drivelineassembly, the external controller assembly comprising an externaldriveline assembly and an external controller via which power issupplied to the blood pump, the external driveline assembly comprisingan external driveline cable and an external driveline distal connector,the external driveline cable connecting the external driveline distalconnector and the external controller, the external controllercomprising an external controller display viewable by the patient, theexternal driveline cable and the intermediate driveline assemblyaccommodating positioning of the external driveline distal connector andthe intermediate driveline proximal connector, by the patient, forsimultaneous viewing and disconnection of the external driveline distalconnector and the intermediate driveline proximal connector and theexternal controller display by the patient; detecting whether theexternal driveline distal connector is connected to the intermediatedriveline proximal connector; and displaying an indication on theexternal controller display indicative of whether the external drivelineassembly is connected to the intermediate driveline assembly.
 13. Themethod of claim 12, further comprising securing the intermediatedriveline distal connector to the percutaneous driveline proximalconnector so as to prevent the patient from disconnecting theintermediate driveline distal connector from the percutaneous drivelineproximal connector without use of a tool.
 14. The method of claim 12,further comprising: connecting the external driveline assembly to theexternal controller by connecting an external driveline proximalconnector of the external driveline assembly to an external drivelineconnection port of the external controller; and securing the externaldriveline proximal connector to the external driveline connection portso as to prevent the patient from disconnecting the external drivelineproximal connector from the external driveline connection port withoutuse of a tool.
 15. The method of claim 12, wherein: the externaldriveline cable has a length from 5 inches to 9 inches; and a length ofthe intermediate driveline assembly and the percutaneous drivelineassembly to the skin-interface segment is from 3.0 inches to 7.0 inches.16. An external controller assembly for an implanted blood pumpassembly, the external controller assembly comprising: an externalcontroller via which power is supplied to the implanted blood pumpassembly, the external controller including an external controllerdisplay viewable by a patient in which the implanted blood pump assemblyis implanted; an external driveline assembly comprising an externaldriveline cable and an external driveline distal connector, the externaldriveline cable being connected to the external driveline distalconnector and the external controller; and an intermediate drivelineassembly comprising an intermediate driveline cable, an intermediatedriveline proximal connector, and an intermediate driveline distalconnector; wherein the intermediate driveline proximal connector isadapted to be connected to the external driveline distal connector bythe patient, wherein the intermediate driveline proximal connector isadapted to be disconnected to the external driveline distal connector bythe patient, wherein the intermediate driveline distal connector isadapted to be connected to a percutaneous cable proximal connector of apercutaneous driveline assembly connected to the implanted blood pumpassembly, wherein the intermediate driveline assembly and thepercutaneous driveline assembly have a flexibility and an exteriorlength from a skin-interface segment of the percutaneous drivelineassembly to the intermediate driveline proximal connector thataccommodates positioning of the intermediate driveline proximalconnector, by the patient, between the external controller display andan eye of the patient, and wherein a length of the intermediatedriveline assembly and the percutaneous driveline assembly to theskin-interface segment is from 3.0 inches to 7.0 inches, wherein theexternal controller and the external driveline assembly are adapted todetect whether the external driveline assembly is connected to theintermediate driveline assembly and display an indication on theexternal controller display indicative of whether the external drivelineassembly is connected to the intermediate driveline assembly.
 17. Theexternal controller assembly of claim 16, wherein the external drivelinecable has a length and a flexibility to accommodate the positioning ofthe external driveline distal connector, by the patient, forsimultaneous viewing of the external driveline distal connector and theexternal controller display by the patient.
 18. The external controllerassembly of claim 17, wherein the length of the external driveline cableis from 5 inches to 9 inches.
 19. The external controller assembly ofclaim 18, wherein: the external controller comprises an externaldriveline connection port; the external driveline assembly comprises anexternal driveline proximal connector that connects the externaldriveline cable to the external driveline connection port; and theexternal controller comprises an external driveline latching mechanismthat prevents the patient from disconnecting the external drivelineproximal connector from the external driveline connection port withoutuse of a tool.
 20. The external controller assembly of claim 16,wherein: the external driveline assembly comprises a first connectionlead and a second connection lead; the second connection lead iselectrically connected to the first connection lead while the externaldriveline distal connector is connected to the intermediate drivelineproximal connector; the second connection lead is electricallydisconnected from the first connection lead while the external drivelinedistal connector is not connected to the intermediate driveline proximalconnector; and the external controller detects whether the externaldriveline distal connector is connected to the intermediate drivelineproximal connector by detecting whether the second connection lead iselectrically connected to the first connection lead.